Medtronic Gloves in AMS Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 39 Major Pack kits containing Medtronic gloves that may have splits or holes compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 39 kits of the Major Pack (1345), part number AMS6565. These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lot number is 101254, with an expiration date of 10/14/2019.
The products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington. Consumers and healthcare facilities should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Major Pack (1345), part number AMS6565
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number and expiration date 101254
- 10/14/2019
Distribution
Part of a larger recall action
This product is one of 124 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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